Device recall
Z-1772-2022: The Randox Serology I Positive Control contains the following analytes in human…
FDA device recall · Class II · Randox Laboratories Ltd.
Key facts
| Recall number (Z-number) | Z-1772-2022 |
|---|---|
| Recall event | 90777 |
| Product | The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each. |
| Product code | OHQ |
| Recalling firm | Randox Laboratories Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 13, 2024 |
| FEI number | 1000361607 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database